ACRP -CP Exam Review(Based on Declaration of
Helsinki and ICH E2A, E6_R2, E8, E9, E11)Rated
100% Correct!!
Adverse Drug Reaction (ADR)- Answer All noxious and unintended responses to a medicinal
product related to any dose (causal relationship is at least a reasonable possibility). Regarding
marketed medicinal products: a response to a drug which is noxious d unintended
an and which
occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for
modification of physiological function
Adverse Event (AE)- Answer Any untoward medical occurrence in a patient or clinical
investigation subject administered a pharmaceutical product and which does not necessarily have a
causal relationship with this treatment. (ICH GCP E6 1.2)
Audit - Answer A systematic and independent examination of trial related activities and
documents to determine whether the evaluated trial related activities were conducted, and the data
were recorded, analyzed and accurately reported according to theocol,
protsponsor's standard
operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory
requirement(s).
Audit Trail - Answer Documentation that allows reconstruction of the course of events.
Blinding/Masking- Answer A procedure in which one or more parties to the trial are kept unaware
of the treatment assignment. Single
-blinding usually refers to the subject(s) being unaware, and
double- blinding usually refers to the subject(s), investigato
r(s), monitor, and, in some cases, data
analyst(s) being unaware of the treatment assignment(s). (ICH GCP E6 1.10)
Case Report Form (CRF)- Answer A printed, optical, or electronic document designed to record all
of the protocol required information to be reported to the sponsor on each trial subject.
Clinical Trial/Study- Answer Any investigation in human subjects intended to discover or verify
the clinical, pharmacological and/or other pharmacodynamic effects of an investigational
product(s), and/or to identify any adverse reactions to an investigati
onal product(s), and/or to
study absorption, distribution, metabolism, and excretion of an investigational product(s) with the
object of ascertaining its safety and/or efficacy.
Clinical Trial/Study Report- Answer A written description of a trial/study of any therapeutic,
prophylactic or diagnostic agent conducted in human subjects, in which the clinical and statistical
description, presentations, and analysis are fully integrate
d into a single report. (ICH GCP E6 1.13)
, ACRP -CP Exam Review(Based on Declaration of
Helsinki and ICH E2A, E6_R2, E8, E9, E11)Rated
100% Correct!!
Comparator (Product)- Answer An investigational or marketed product (i.e., active control), or
placebo, used as a reference in a clinical trial.
Compliance (in relation to trials)
- Answer Adherence to all the trial
-related requirements, Good
Clinical Practice (GCP) requirements, and the applicable regulatory requirements.
Direct Access- Answer Permission to examine, analyze, verify, and reproduce any records and
reports that are important to evaluation of a clinical trial.
Documentation- Answer All records, in any form (including, but not limited to, written,
electronic, magnetic, and optical records, and scans,
-rays,
x and electrocardiograms) that describe
or record the methods, conduct, and/or results of a trial, the
orsfact
affecting a trial, and the actions
taken.
Essential Documents- Answer Documents which individually and collectively permit evaluation of
the conduct of a study and the quality of the data produced.
Good Clinical Practice (GCP)- Answer A standard for the design, conduct, performance,
monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance
that the data and reported results are credible and accurate, and
t thetha
rights, integrity, and
confidentiality of trial subjects are protected.
Impartial Witness- Answer A person, who is independent of the trial, who cannot be unfairly
influenced by people involved with the trial, who attends the informed consent process if the
subject or the subject's legally acceptable representative cannot
d, and
reawho reads the informed
consent form and any other written information supplied to the subject.
Informed Consent- Answer A process by which a subject voluntarily confirms his or her
willingness to participate in a particular trial, after having been informed of all aspects of the trial
that are relevant to the subject's decision to participate.rmed
Infoconsent is documented by means
of a written, signed and dated informed consent form.
Inspection- Answer The act by a regulatory authority(ies) of conducting an official review of
documents, facilities, records, and any other resources that are deemed by the authority(ies) to be
related to the clinical trial and that may be located at
site
theof the trial, at the sponsor's and/or
Helsinki and ICH E2A, E6_R2, E8, E9, E11)Rated
100% Correct!!
Adverse Drug Reaction (ADR)- Answer All noxious and unintended responses to a medicinal
product related to any dose (causal relationship is at least a reasonable possibility). Regarding
marketed medicinal products: a response to a drug which is noxious d unintended
an and which
occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for
modification of physiological function
Adverse Event (AE)- Answer Any untoward medical occurrence in a patient or clinical
investigation subject administered a pharmaceutical product and which does not necessarily have a
causal relationship with this treatment. (ICH GCP E6 1.2)
Audit - Answer A systematic and independent examination of trial related activities and
documents to determine whether the evaluated trial related activities were conducted, and the data
were recorded, analyzed and accurately reported according to theocol,
protsponsor's standard
operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory
requirement(s).
Audit Trail - Answer Documentation that allows reconstruction of the course of events.
Blinding/Masking- Answer A procedure in which one or more parties to the trial are kept unaware
of the treatment assignment. Single
-blinding usually refers to the subject(s) being unaware, and
double- blinding usually refers to the subject(s), investigato
r(s), monitor, and, in some cases, data
analyst(s) being unaware of the treatment assignment(s). (ICH GCP E6 1.10)
Case Report Form (CRF)- Answer A printed, optical, or electronic document designed to record all
of the protocol required information to be reported to the sponsor on each trial subject.
Clinical Trial/Study- Answer Any investigation in human subjects intended to discover or verify
the clinical, pharmacological and/or other pharmacodynamic effects of an investigational
product(s), and/or to identify any adverse reactions to an investigati
onal product(s), and/or to
study absorption, distribution, metabolism, and excretion of an investigational product(s) with the
object of ascertaining its safety and/or efficacy.
Clinical Trial/Study Report- Answer A written description of a trial/study of any therapeutic,
prophylactic or diagnostic agent conducted in human subjects, in which the clinical and statistical
description, presentations, and analysis are fully integrate
d into a single report. (ICH GCP E6 1.13)
, ACRP -CP Exam Review(Based on Declaration of
Helsinki and ICH E2A, E6_R2, E8, E9, E11)Rated
100% Correct!!
Comparator (Product)- Answer An investigational or marketed product (i.e., active control), or
placebo, used as a reference in a clinical trial.
Compliance (in relation to trials)
- Answer Adherence to all the trial
-related requirements, Good
Clinical Practice (GCP) requirements, and the applicable regulatory requirements.
Direct Access- Answer Permission to examine, analyze, verify, and reproduce any records and
reports that are important to evaluation of a clinical trial.
Documentation- Answer All records, in any form (including, but not limited to, written,
electronic, magnetic, and optical records, and scans,
-rays,
x and electrocardiograms) that describe
or record the methods, conduct, and/or results of a trial, the
orsfact
affecting a trial, and the actions
taken.
Essential Documents- Answer Documents which individually and collectively permit evaluation of
the conduct of a study and the quality of the data produced.
Good Clinical Practice (GCP)- Answer A standard for the design, conduct, performance,
monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance
that the data and reported results are credible and accurate, and
t thetha
rights, integrity, and
confidentiality of trial subjects are protected.
Impartial Witness- Answer A person, who is independent of the trial, who cannot be unfairly
influenced by people involved with the trial, who attends the informed consent process if the
subject or the subject's legally acceptable representative cannot
d, and
reawho reads the informed
consent form and any other written information supplied to the subject.
Informed Consent- Answer A process by which a subject voluntarily confirms his or her
willingness to participate in a particular trial, after having been informed of all aspects of the trial
that are relevant to the subject's decision to participate.rmed
Infoconsent is documented by means
of a written, signed and dated informed consent form.
Inspection- Answer The act by a regulatory authority(ies) of conducting an official review of
documents, facilities, records, and any other resources that are deemed by the authority(ies) to be
related to the clinical trial and that may be located at
site
theof the trial, at the sponsor's and/or
